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U.S. Department of Health and Human Services

Medical Devices

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ProGEL™ Pleural Air Leak Sealant - P010047

Product name: ProGEL™ Pleural Air Leak Sealant

PMA Applicant: NeoMend, Inc

Address: 60 Technology Dr., Irvine, CA 92618

Approval Date: January 14, 2010

Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/P010047a.pdf

What is it? The ProGEL™ Pleural Air Leak Sealant is a surgical sealant made of human serum albumin and a polyethylene glycol (PEG) crosslinker that forms a clear flexible gel on mixing. Surgeons use the device to seal air leaks on lung tissue after standard closure techniques, (that is, sutures or staples) for open resection of lung tissue.

How does it work? ProGEL™ Pleural Air Leak Sealant is sprayed or “painted” on the lung tissue. The ProGEL™ forms on the lung tissue by chemical reaction.

When is it used? Diagnosis of lung cancer often requires surgical removal of lung tumors. After tumors are removed, air leaks can develop around the sutures or staples used to close the surgical procedure. Currently, air leaks are closed by suturing and stapling tissue or applying a surgical mesh over the air leak. In some patients, lung tissue is so fragile that surgeons do not try to use these usual closure methods. Surgeons can now use the ProGEL™Pleural Air Leak Sealant to close lung tissue in addition to these standard surgical closure methods.

What will it accomplish? Clinical studies showed that 35% of patients treated with ProGEL™Pleural Air Leak Sealant and standard surgical closure techniques were air-leak free when they were discharged from the hospital compared to 14% percent of patients treated with standard techniques alone. The studies also showed ProGEL™ use improved: 1) the number of air leaks occurring during lung surgery and 2) the number of patients who were air-leak free immediately after surgery compared to standard surgical techniques. While the incidence and severity of side effects for both treatment groups were similar, the total number of adverse events related to kidney function was higher in the ProGEL™ (9.5%) than the control (3.8%) subjects.

When should it not be used? ProGEL™ should not be used if patients are allergic to human blood proteinsor iftheyhave problems with kidney function. It should also not be used after surgery for open or closed defects of the branches of the air pipe that lead to the lung due to a possible increase in the incidence of undesired air passageways between thelungand the tissue surrounding the lung. This includes patients: 1) undergoing surgical removal of a large portion of lung tissue, 2) surgery to remove a lung lobe and a part of the main airway, or 3)surgical repair of one branch of the air pipe that leads to the lung. ProGEL™’s ability to seal is reduced or lost when applied over surgical sponges.

Additional information:

The Summary and Safety and Effectiveness and product labeling are available online.